A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
研究概览
简要总结
The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. As secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the EVADO system on the coagulation cascade and inflammatory activation.
详细描述
The present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial.
Participating centres are selected based on previous experience with the use of the EVADO system.
Patients elected to open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination in the participating centers will be screened.
This study as secondary aim wants to confirm the results of earlier investigation by a multicentre trial conducted on a larger population of patients undergoing a wide spectrum of open heart cardiac operations and either assess a number of cost-efficacy-efficiency indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients elected to undergo open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination and fulfilling the following additional criteria:
- •Written informed consent
- •Age 18-85 years
排除标准
- •Severe renal or liver failure
- •Uncompensated diabetes
- •Autoimmune disease requiring immunosuppressant therapy
- •Coagulation disorders
- •Emergent or redo surgery
研究组 & 干预措施
EVADO
The E.V.A.D.O. system is made of the following components:
- The ADMIRAL oxygenator, that requires low priming volumes (, has a limited contact surface and contains an accessory independent cardiotomy reservoir, allowing separation of pericardial suction blood.
- The HARMONY Smart Suction System, which allows automatic regulation of a pumpless extracavity blood sucker, whose rates and pressures depend on whether suction is required for blood/air surfaces (skimming), or for fluids (pooled).
- Paediatric circuits with 3/8" tubing for both arterial and venous lines.
干预措施: EVADO (Device)
Conventional CPB
conventional cardiopulmonary by-pass (CPB) system
干预措施: Conventional CPB (Device)
结局指标
主要结局
composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The primary efficacy endpoint is the composite of in-hospital mortality, defined as death of any cause occurring before hospital discharge, myocardial infarction, stroke; severe renal failure; severe liver failure; severe cardio-respiratory failure; multiorgan failure; need for left ventricular support device; need for dialysis or ultrafiltration: post-operative bleeding; atrial fibrillation.
次要结局
- Individual components of the primary end-point(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)